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This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 µg Brimonidine Tartrate Implant Group B | Experimental | 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
|
| 200 µg Brimonidine Tartrate Implant Group B | Experimental | 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
|
| 100 µg Brimonidine Tartrate Implant Group B | Experimental | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
|
| 100 µg Brimonidine Tartrate Implant Group A | Experimental | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 µg Brimonidine Tartrate Implant | Drug | 400 µg brimonidine tartrate implant in the study eye on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. | Baseline, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Contrast Sensitivity in the Study Eye | Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arlington | Texas | United States | ||||
Patients were stratified by Best Corrected Visual Acuity (BCVA). Patients assigned to Group A had a BCVA of 20/320. Patients assigned to Group B had a BCVA worse than 20/40 and better than 20/320. Patients in Group A were randomized and treated prior to initiating enrollment in Group B. No patients from Group A participated in Group B.
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| ID | Title | Description |
|---|---|---|
| FG000 | 400 µg Brimonidine Tartrate Implant Group B | 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| FG001 | 200 µg Brimonidine Tartrate Implant Group B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 200 µg Brimonidine Tartrate Implant | Drug | 200 µg brimonidine tartrate implant in the study eye on Day 1. |
|
|
| 100 µg Brimonidine Tartrate Implant | Drug | 100 µg brimonidine tartrate implant in the study eye on Day 1. |
|
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| Sham (no implant) | Other | Sham in the fellow eye on Day 1. |
|
| Baseline, Month 6 |
| Paris |
| France |
| Tübingen | Germany |
| Coimbra | Portugal |
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
| FG002 | 100 µg Brimonidine Tartrate Implant Group B | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| FG003 | 100 µg Brimonidine Tartrate Implant Group A | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 400 µg Brimonidine Tartrate Implant Group B | 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| BG001 | 200 µg Brimonidine Tartrate Implant Group B | 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| BG002 | 100 µg Brimonidine Tartrate Implant Group B | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| BG003 | 100 µg Brimonidine Tartrate Implant Group A | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. | Safety Population: all patients treated on Day 1 | Posted | Mean | Standard Deviation | Number of Letters Read Correctly | Baseline, Month 6 |
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| Secondary | Change From Baseline in Contrast Sensitivity in the Study Eye | Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement. | Safety Population: all patients treated on Day 1 | Posted | Mean | Standard Deviation | Number of Letters Read Correctly | Baseline, Month 6 |
|
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For Ocular AEs, only those occurring in the study eye are reported in the "Other Adverse Events" section. For SAEs, all ocular events were reported, regardless of eye.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 400 µg Brimonidine Tartrate Implant Group B | 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | 1 | 12 | 11 | 12 | ||
| EG001 | 200 µg Brimonidine Tartrate Implant Group B | 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | 0 | 3 | 3 | 3 | ||
| EG002 | 100 µg Brimonidine Tartrate Implant Groups A and B | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. | 1 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
| |
| Myelitis | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhage | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Conjunctival Hyperaemia | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Foreign Body Sensation in Eyes | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Ocular Discomfort | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Glare | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Conjunctival Oedema | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Bite | Injury, poisoning and procedural complications | MedDRA version 10.0 | Non-systematic Assessment |
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| Colour Blindness | Congenital, familial and genetic disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Conjunctivitis Allergic | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Dry Eye | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Epididymitis | Reproductive system and breast disorders | MedDRA version 10.0 | Systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Foot Fracture | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Lacrimation Increased | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Ligament Injury | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA version 10.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA version 10.0 | Non-systematic Assessment |
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| Visual Disturbance | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Abnormal Sensation in Eye | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Bacteriuria | Infections and infestations | MedDRA version 10.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Ear Pain | Ear and labyrinth disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Keratitis | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Muscle Contracture | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Myelitis | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Prostate Infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Renal Injury | Injury, poisoning and procedural complications | MedDRA version 10.0 | Systematic Assessment |
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| Restless Legs Syndrome | Nervous system disorders | MedDRA version 10.0 | Systematic Assessment |
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| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA version 10.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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| Visual Acuity Reduced | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Vitreous Floaters | Eye disorders | MedDRA version 10.0 | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA version 10.0 | Systematic Assessment |
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| Dental Caries | Gastrointestinal disorders | MedDRA version 10.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA version 10.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Change from Baseline at Month 6 |
|
| OG003 |
| 100 µg Brimonidine Tartrate Implant Group A |
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
|
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